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Enekinragene inzadenovec (PCRX-201, formerly FX201 or HCAd-IL-1RA) is an investigational, locally administered gene therapy designed for the treatment of osteoarthritis (OA) of the knee. It consists of a high-capacity, non-replicating adenovirus serotype 5 (Ad5) vector encoding human interleukin-1 receptor antagonist (IL-1Ra) under the control of an inflammation-inducible nuclear factor kappa B (NF-κB) promoter. This design allows for 'on-demand' production of IL-1Ra in response to joint inflammation, blocking the interleukin-1 (IL-1) pathway to reduce chronic inflammation, alleviate pain, and potentially modify disease progression. Originally developed at Baylor College of Medicine and GQ Bio Therapeutics (formerly GeneQuine Biotherapeutics), the asset was licensed by Flexion Therapeutics (later acquired by Pacira BioSciences). It is currently in Phase 2 clinical development.
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